everolimus in treating patients with relapsed or metastatic endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.

objectives: primary * estimate the rate of non-progression after 3 months of treatment with everolimus in patients with relapsed or metastatic endometrial cancer. secondary * evaluate the partial and complete response rate after 3 months of treatment with everolimus in these patients. * evaluate the duration of response in these patients. * evaluate the clinical benefit after 6 months of treatment with everolimus in these patients. * evaluate the time to progression in these patients. * evaluate the progression-free and overall survival of these patients. * evaluate the nature, frequency, and severity of side effects of everolimus in these patients. outline: this is a multicenter study. patients receive oral everolimus daily in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed monthly for 3 months and then every 3 months thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the endometrium * metastatic disease after first- or second-line chemotherapy * previously treated with platinum-based therapy in the adjuvant or metastatic setting * must have ≥ 1 measurable metastatic lesion outside previously irradiated areas * no locally recurrent resectable tumor * no uncontrolled brain metastases patient characteristics: * who performance status 0-1 * anc ≥ 1,000/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9 g/dl * transaminases ≤ 2.5 times upper limit of normal (uln) (≤ 5 times uln in the presence of liver metastases) * alkaline phosphatase ≤ 2.5 times uln * bilirubin ≤ 1.5 times uln * creatinine clearance ≥ 50 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other cancer within the past 3 years except for curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma * no concurrent serious and/or uncontrolled disease that would preclude study participation, including any of the following: * uncontrolled diabetes * uncontrolled hypertension * severe infection * profound malnutrition * unstable angina * nyha class iii-iv congestive heart failure * ventricular arrhythmia * coronary artery disease * myocardial infarction within the past 6 months * liver disease * chronic renal failure * progressive ulceration of the upper gastrointestinal tract * no hypersensitivity to everolimus, sirolimus, or lactose * no abnormalities ≥ grade 3 * no psychological, familial, social, or geographical reasons that would preclude study follow-up * no history of poor compliance to medical treatment prior concurrent therapy: * see disease characteristics * no prior experimental drugs (e.g., mtor inhibitors) * more than 21 days since prior and no other concurrent chemotherapy, hormonal therapy, or antitumor therapy * more than 5 days since prior strong cyp3a4 inhibitors or inducers (e.g., rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin) * more than 30 days since other prior treatments * no concurrent participation in another clinical trial that would interfere with the objectives of this study * no concurrent anticoagulation, except for 1 mg of coumadin per day or low molecular weight heparin

Keywords: recurrent endometrial carcinoma stage iv endometrial carcinoma endometrial adenocarcinoma